Manager Regulatory Affairs Operations

Acadia Pharmaceuticals Job Posting

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we're here to be their difference.

This position is based in San Diego, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Regulatory Operations Manager is responsible for publishing, QC, and transmittal of eCTD submissions. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions in alignment with health authority guidelines and industry best practices. This individual will have a clear understanding of electronic submission requirements including the eCTD structure, Word templates and styles.

Primary Responsibilities

• Using Acadia's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions in alignment with health authority guidelines and industry best practices.
• For authored documents, provide guidance on formatting and review for adherence to Acadia's Style Guide.
• Perform document verifications and follow procedures to identify, document, and communicate findings.
• Manage document management tasks including file transfer, storage, tracking, and archival services.
• Provide training to cross functional teams on Acadia style guide and Acadia authoring templates.
• Validate and QC published eCTD submissions, working collaboratively with teammates to resolve findings and issues.
• Support authors and contributors providing guidance on electronic document requirements to be included in regulatory submissions.
• Utilize Electronic Submission Gateway (ESG) to transmit submissions to FDA and other Health Authorities.
• Update trackers, correspondence logs, metrics on daily / weekly / monthly basis as internal policies dictate.
• Other activities as designated.

Education / Experience / Skills

Requires a Bachelor's degree in Business Administration, Life Science discipline or related field. Targeting 5 years of experience in Regulatory Affairs Operations or relevant function. An equivalent combination of relevant education and experience may be considered.

Working knowledge of eCTD guidances (e.g., ICH, FDA, EMA, etc.), requirements, and technologies.

Knowledge, understanding, and experience with Veeva VAULT RIM authoring workflows, document metadata, and naming conventions.

Strong working knowledge of tools and technologies related to document formatting / document-level publishing (e.g., Word, Acrobat, DXC Toolbox, authoring templates).

Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports.

Demonstrated ability to effectively communicate in written and verbal media concepts related to regulatory systems and electronic submissions.

Ability to deliver while working under pressure to meet tight deadlines.

Physical Requirements : This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and / or move up to 20 pounds. This position requires the ability to travel independently overnight and / or work after hours as required by travel schedules or business needs.

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range : $91,000$113,700 USD

What we offer US-based Employees :

EEO Statement (US-based Employees) : Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn't exactly what we describe here. It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law. As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923.